SAPROPTERIN DIHYDROCHLORIDE Drug Patent Profile
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When do Sapropterin Dihydrochloride patents expire, and when can generic versions of Sapropterin Dihydrochloride launch?
Sapropterin Dihydrochloride is a drug marketed by Annora Pharma, Dr Reddys, and Endo Operations. and is included in eight NDAs.
The generic ingredient in SAPROPTERIN DIHYDROCHLORIDE is sapropterin dihydrochloride. There are three drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the sapropterin dihydrochloride profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Sapropterin Dihydrochloride
A generic version of SAPROPTERIN DIHYDROCHLORIDE was approved as sapropterin dihydrochloride by ENDO OPERATIONS on May 10th, 2019.
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Questions you can ask:
- What is the 5 year forecast for SAPROPTERIN DIHYDROCHLORIDE?
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- What is Average Wholesale Price for SAPROPTERIN DIHYDROCHLORIDE?
Summary for SAPROPTERIN DIHYDROCHLORIDE
| US Patents: | 0 |
| Applicants: | 3 |
| NDAs: | 8 |
| Finished Product Suppliers / Packagers: | 4 |
| Raw Ingredient (Bulk) Api Vendors: | 64 |
| Clinical Trials: | 38 |
| Patent Applications: | 169 |
| Drug Prices: | Drug price information for SAPROPTERIN DIHYDROCHLORIDE |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for SAPROPTERIN DIHYDROCHLORIDE |
| What excipients (inactive ingredients) are in SAPROPTERIN DIHYDROCHLORIDE? | SAPROPTERIN DIHYDROCHLORIDE excipients list |
| DailyMed Link: | SAPROPTERIN DIHYDROCHLORIDE at DailyMed |
Recent Clinical Trials for SAPROPTERIN DIHYDROCHLORIDE
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| West China Hospital | Phase 1 |
| Ira Fox | Phase 1/Phase 2 |
| West China Second University Hospital | Phase 2 |
Pharmacology for SAPROPTERIN DIHYDROCHLORIDE
Anatomical Therapeutic Chemical (ATC) Classes for SAPROPTERIN DIHYDROCHLORIDE
Paragraph IV (Patent) Challenges for SAPROPTERIN DIHYDROCHLORIDE
| Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
|---|---|---|---|---|---|---|
| KUVAN | Powder for Oral Solution | sapropterin dihydrochloride | 500 mg per packet | 205065 | 1 | 2017-02-23 |
| KUVAN | Powder for Oral Solution | sapropterin dihydrochloride | 100 mg per packet | 205065 | 1 | 2015-11-09 |
| KUVAN | Tablets | sapropterin dihydrochloride | 100 mg | 022181 | 1 | 2014-06-05 |
US Patents and Regulatory Information for SAPROPTERIN DIHYDROCHLORIDE
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Annora Pharma | SAPROPTERIN DIHYDROCHLORIDE | sapropterin dihydrochloride | POWDER;ORAL | 215420-001 | Aug 18, 2022 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Annora Pharma | SAPROPTERIN DIHYDROCHLORIDE | sapropterin dihydrochloride | TABLET;ORAL | 215534-001 | Aug 23, 2022 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Dr Reddys | SAPROPTERIN DIHYDROCHLORIDE | sapropterin dihydrochloride | POWDER;ORAL | 215798-001 | May 13, 2022 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Dr Reddys | SAPROPTERIN DIHYDROCHLORIDE | sapropterin dihydrochloride | TABLET;ORAL | 207685-001 | Jun 15, 2021 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Annora Pharma | SAPROPTERIN DIHYDROCHLORIDE | sapropterin dihydrochloride | POWDER;ORAL | 215420-002 | Aug 18, 2022 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
